Novel preclinical method for evaluating the efficacy of a percutaneous treatment in human ex vivo calcified plaque

March 20, 2021

Robert S. Chisena (1), Jordan Sengenberger (2), Albert J. Shih (1), Hitinder Gurm (3)
Medical & Biological Engineering & Computing, 59, March 2021: 799–811. DOI: 10.1007/s11517-021-02334-w


Microcomputed tomography; Noncompliant balloon angioplasty; Preclinical efficacy evaluation model; Ex vivo calcified plaque model


The lack of suitable atherosclerotic calcification models and testing strategies inhibits preclinical efficacy testing of existing and novel percutaneous devices. The goal of this study is to develop a preclinical testing method for quantitatively and qualitatively evaluating the efficacy of noncompliant balloon angioplasty (NC BA) treatment in human ex vivo calcified plaque (CP). NC BA using a 3- and 4-mm diameter balloon was performed on an ex vivo tibial calcified vessel obtained from an amputation. Three-dimensional microcomputed tomography (μ-CT) imaging was performed pre- and post-BA to compare crack density in the CP. Comparing the pre- and posttreatment three-dimensional μ-CT images showed a glass-like cracking that occurred in the CP due to the BA procedure. Expansion of the 3-mm balloon showed little tissue deformation and no CP cracking. Although expansion of the 4-mm balloon occurred nonuniformly along balloon length and across the perpendicular projections, the balloon generated cracking throughout the CP, which allowed the surrounding elastic tissue to be dilated. This combined X-ray microscopy and μ-CT technique is a useful preclinical tool for quantifying the efficacy of percutaneous treatments for CP. Because of its nondestructive nature, the CP structure can be visualized pre- and posttreatment to determine the treatment effect.

How Our Software Was Used

Dragonfly was used to perform 3D reconstruction, visualization and segmentation of CT data. It was also used to measure the local thickness of cracks in a tibial calcified vessel.

Author Affiliation

(1) Department of Mechanical Engineering, University of Michigan at Ann Arbor, 2350 Hayward St, Ann Arbor, MI 48109, USA.
(2) Department of Biomedical Engineering, University of Michigan at Ann Arbor, 2200 Bonisteel Blvd, Ann Arbor, MI 48109, USA.
(3) Department of Internal Medicine, University of Michigan Health System at Ann Arbor, 1500 E Medical Center Dr, Ann Arbor, MI 48109, USA.